Product Dossier
E-MYCIN
Product Dossier for E-MYCIN (Erythromycin ethylsuccinate, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: Erythromycin ethylsuccinate
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
I appreciate your request, but
I must inform you that the provided source document contains only ARTG registration records for E-MYCIN and does not include the clinical, safety, dosing, or regulatory information necessary to create a comprehensive Brand Dossier. The available information confirms that E-MYCIN is an erythromycin ethylsuccinate formulation sponsored by Alphapharm, with three variants registered on the ARTG: a 200 mg/5 mL oral liquid powder (first listed 1994), a 400 mg/5 mL oral liquid powder (first listed 1994), and a 400 mg tablet (first listed 1999). To produce a Brand Dossier according to the specified format, I would require source documents containing: — Approved therapeutic indications — Dosing recommendations by indication — Key safety warnings and adverse effects — Contraindications and precautions — PBS listing details (if applicable) — PBAC assessment outcomes and dates — AusPAR documentation — Any Black Triangle status information
Please provide additional source documents with this clinical and regulatory information to enable preparation of the complete dossier.